tbuckley/cabot-search huggingface dataset:
Application of Patient-Reported Outcome Measurements in Clinical Trials in China
Authors: Hui Zhou, Mi Yao, Xiaodan Gu, Mingrui Liu, Ruifeng Zeng, Qin Li, Tingjia Chen, Wen He, Xiao Chen, Gang Yuan
Journal: JAMA Network Open (2022)

Regulatory authorities, industry peers, and international health policies have emphasized the value of assessing patient-reported outcomes (PROs) in clinical studies. Despite the increase in the number of clinical studies in the last decade in China, little is known about the extent of the use of PROs.To evaluate the application and characteristics of PRO instruments as primary and secondary outcomes in randomized clinical trials in China.A cross-sectional study of interventional clinical trials conducted in China from January 1, 2010, to December 31, 2020, was performed. Data obtained from the Chinese Clinical Trial Registry and ClinicalTrials.gov databases were evaluated.Trials were categorized according to those that (1) precisely listed PRO tools as outcomes, (2) mentioned patient subjective feelings in outcomes but did not clarify which tools were used for assessment, and (3) did not mention any PRO measurements. Data on study phase, setting, participant age, and sex were extracted from trials that considered patient feelings, along with the target diseases and names of the PRO tools.Among a total of 34 033 trials, 6915 (20.3%) listed the explicit PRO instruments used and 3178 (9.3%) included PRO in their outcomes but did not include the names of the assessment tools. From more than 32 million people included in the registered trials, data on 1.5 million (4.7%) patients were scientifically collected by PRO instruments, and subjective feelings were assessed for 693 867 (2.1%) participants. Pain (16.8%), cancer (15.6%), and musculoskeletal symptoms (13.3%) were the most common conditions for which PROs were precisely collected by tools. The most common tools for PRO measurements were the visual analog scale, Short-Form 36, and Hamilton Depression Scale.In this cross-sectional study, the use of PROs increased during the study period in clinical trials conducted in China. However, patient opinion appears to still be rarely measured. The application of PRO is geographically unevenly distributed. Development of PRO instruments, especially those suitable for the Chinese population, may be useful. Further expansion of PROs with respect to the scope of diseases is needed to avoid missing important data.
PD-1 Inhibition—Trouble for Subsequent TIL Therapy in Patients with Melanoma?
Authors: Eryn Blass, Patrick A. Ott
Journal: Clinical Cancer Research (2022)

Summary To explore the lower efficacy of adoptive cell transfer (ACT) therapy in patients with anti–PD-1 experienced melanoma, tumor mutational burden (TMB), predicted neoantigen frequencies, and tumor-infiltrating lymphocyte (TIL) neoantigen reactivity were assessed. Reduced neoantigen-specific TIL frequencies correlated with lower ACT response even in patients with similar TMB, suggesting a potentially harmful effect of PD-1 inhibition on T-cell outgrowth. See related article by Levi et al., p. 3042
Ruxolitinib versus best available therapy in inadequately controlled polycythaemia vera without splenomegaly (RESPONSE-2): 5-year follow up of a randomised, phase 3b study
Authors: Francesco Passamonti, Francesca Palandri, Guray Saydam, Jeannie Callum, Timothy Devos, Paola Guglielmelli, Alessandro M Vannucchi, Evren Zor, Mike Zuurman, Geralyn Gilotti, Yifan Zhang, Martin Griesshammer
Journal: The Lancet Haematology (2022)
COVID-19 Vaccination Preferences of University Students and Staff in Hong Kong
Authors: Lydia W. Y. Fung, Jiaxi Zhao, Vincent K. C. Yan, Joseph E. Blais, Jacky C. H. Chan, Silvia T. H. Li, Jessica J. P. Shami, Christine Kwan, Yue Wei, Carlos K. H. Wong, Xue Li, Celine S. L. Chui, Eric Y. F. Wan, Francisco T. T. Lai, Samson Tse, Benjamin J. Cowling, Ian C. K. Wong, Esther W. Chan
Journal: JAMA Network Open (2022)

COVID-19 has required universities to rapidly develop vaccination policies for students and staff, yet little is known about the preferences of these individuals toward vaccination.To quantify student and staff preferences for COVID-19 vaccination at a university in Hong Kong.A cross-sectional online survey study was conducted from July 20 to September 21, 2021, before the announcement of a campus-wide vaccine mandate. A survey of 42 451 eligible university students and staff used discrete-choice experiment methods to quantify 7 attributes of COVID-19 vaccination: risk of a mild or moderate adverse event after vaccination, risk of a severe adverse event after vaccination, efficacy against COVID-19 infection, efficacy against severe manifestation of COVID-19 infection, duration of protection after vaccination, incentive for completing vaccination, and out-of-pocket costs.A mixed logit regression model was used to estimate the preferences of attributes for COVID-19 vaccines and marginal willingness to pay (mWTP) adjusted for background characteristics, role, vaccination, and COVID-19 infection status of family or friends, adverse event status after vaccination among family and friends of participants, and scenario block.Among 42 451 eligible university students and staff invited, 3423 individuals completed the survey (mean [SD] age, 27.1 [9.9] years; 2053 [60.0%] women). Participants included 2506 students (73.2%) and 917 staff (26.8%), with a response rate of 8.1%. Quarantine-free travel was preferred (β = 0.86; 95% CI, 0.72-0.99; mWTP: $235.9; 95% CI, $190.3-$294.2), followed by efficacy against any COVID-19 infection (β = 0.30; 95% CI, 0.29-0.32; mWTP: $84.1; 95% CI, $71.8-$100.8), against severe manifestation of COVID-19 infection (β = 0.25; 95% CI, 0.24-0.27; mWTP: $69.7; 95% CI, $465-$653), and risk of severe adverse events following vaccination (β = -0.24; 95% CI, -0.27 to -0.21; mWTP: -$66.8; 95% CI, -$81.5 to -$55.3). Participants were less concerned about protection duration (β = 0.17; 95% CI, 0.15-0.18; mWTP: $46.0; 95% CI, $38.6-$56.2) and risk of mild to moderate adverse events (β = -0.12; 95% CI, -0.13 to -0.10; mWTP: -$32.7; 95% CI, -$41.2 to -$26.4).Preference of all attributes were significant and were considered important by the participants for vaccine decision-making. Insights drawn could assist policy makers in future vaccination decisions, such as campus vaccine mandate and requirement of a third dose.
Shape‐Anisotropic Microembolics Generated by Microfluidic Synthesis for Transarterial Embolization Treatment (Adv. Healthcare Mater. 10/2022)
Authors: Yucheng Luo, Yutao Ma, Zijian Chen, Yanan Gao, Yuping Zhou, Xiaoya Liu, Xuezhe Liu, Xu Gao, Zhihua Li, Chuang Liu, Hwa Liang Leo, Hanry Yu, Qiongyu Guo
Journal: Advanced Healthcare Materials (2022)

Shape-Anisotropic Microembolics In article number 2102281, Qiongyu Guo and co-workers develop anisotropically-shaped particulate embolic agents with calibrated sizes using a facile droplet-based microfluidic technique based on a heat-accelerated crosslinking reaction. Compared to conventional spherical embolic particles, the capsule shape-based nonspherical microembolics simultaneously enhance endovascular navigation, penetration depth, and embolization stability, demonstrating distinctive therapeutic effects of shape anisotropy for transcatheter embolotherapies.
Phenotypic Composition of Commercial Anti-CD19 CAR T Cells Affects <i>In Vivo</i> Expansion and Disease Response in Patients with Large B-cell Lymphoma
Authors: Chiara Monfrini, Federico Stella, Vanessa Aragona, Martina Magni, Silva Ljevar, Cristina Vella, Eugenio Fardella, Annalisa Chiappella, Francesca Nanetti, Martina Pennisi, Anna Dodero, Anna Guidetti, Paolo Corradini, Cristiana Carniti
Journal: Clinical Cancer Research (2022)

Abstract Purpose: In clinical trials, the expansion and persistence of chimeric antigen receptor (CAR) T cells correlate with therapeutic efficacy. However, properties of CAR T cells that enable their in vivo proliferation have still to be consistently defined and the role of CAR T bag content has never been investigated in a real-life setting. Experimental Design: Residual cells obtained after washing 61 anti-CD19 CAR T product bags were analyzed to identify tisagenlecleucel/Tisa-cel and axicabtagene ciloleucel/Axi-cel phenotypic features associated with postinfusion CAR T-cell in vivo expansion and with response and survival. Results: While Tisa-cel was characterized by a significant enrichment in CAR+CD4+ T cells with central memory (P &amp;lt; 0.005) and effector (P &amp;lt; 0.005) phenotypes and lower rates of CAR+CD8+ with effector memory (P &amp;lt; 0.005) and naïve-like (P &amp;lt; 0.05) phenotypes as compared with Axi-cel, the two products displayed similar expansion kinetics. In vivo CAR T-cell expansion was influenced by the presence of CAR T with a CD8+ T central memory signature (P &amp;lt; 0.005) in both Tisa-cel and Axi-cel infusion products and was positively associated with response and progression-free survival (P &amp;lt; 0.05). Conclusions: Our data indicate that despite the great heterogeneity of Tisa-cel and Axi-cel products, the differentiation status of the infused cells mediates CAR T-cell in vivo proliferation that is necessary for antitumor response.
Low Surface Accessible Area NanoCoral TiO<sub>2</sub> for the Reduction of Foreign Body Reaction During Implantation
Authors: Fanyu Zhang, Haoning Qi, Wenting Mo, Yueqi Ni, Qin Zhao, Yulan Wang, Shuting Jiang, Qinchao Tang, Yihong Cheng, Xiangheng Xiao, Yufeng Zhang
Journal: Advanced Healthcare Materials (2022)

Abstract The entry of implants triggers the secretion of damage associated molecular patterns (DAMPs) that recruit dendritic cells (DCs) and results in subsequent foreign body reaction (FBR). Though several studies have illustrated that the surface accessible area (SAA) of implants plays a key role in the process of DAMPs release and absorption, the effect of SAA on the immune reaction still remains unknown. Here, a series of TiO 2 plates with different SAA is fabricated to investigate the relationship between SAA and FBR. Compared with larger SAA surface, the aggregation of DC is significantly inhibited by lower SAA surface. Total internal reflection microscopy (TIRFM) and molecular dynamic (MD) simulation show that although high mobility group box 1 (HMGB1) is adsorbed more on plates with lower SAA, the exposure ratio of cysteine (CYS) residue in HMGB1 is significantly decreased in lower SAA group. The lower exposure of CYS reduces the activation of Toll‐like receptors 4 (TLR4), which down‐regulates the expression of myeloid differentiation factor (Myd88)‐TNF receptor associated factor 6 (TRAF6) to inhibit nuclear factor kappa B (NF‐ κ B) signaling. Generally, this study reveals the mechanism of how SAA, a nanoscale property, affects FBR from perspective of DAMPs, and provides a new direction for designing better biocompatible implants.
Increasing skin of color representation in a medical school dermatology course through student and faculty engagement: The Dermatology IDD Image Verification Ensuring Representation of Skin of Color initiative
Authors: Bina Kassamali, Michelle S. Lee, Danny Linggonegoro, Jordan T. Said, Susan Burgin, Ruth Ann Vleugels, Vinod E. Nambudiri
Journal: Journal of the American Academy of Dermatology (2022)
Osilodrostat for the treatment of Cushing's disease: efficacy, stability, and persistence – Authors' reply
Authors: Maria Fleseriu, Frederic Castinetti, Mônica Gadelha, Andrea Giustina, André Lacroix, Shlomo Melmed, John Newell-Price, Rosario Pivonello, Martin Reincke, Beverly M K Biller
Journal: The Lancet Diabetes & Endocrinology (2022)
Estimating the Burden of Influenza-like Illness on Daily Activity at the Population Scale Using Commercial Wearable Sensors
Authors: Aziz Mezlini, Allison Shapiro, Eric J. Daza, Eamon Caddigan, Ernesto Ramirez, Tim Althoff, Luca Foschini
Journal: JAMA Network Open (2022)

<h3>Importance</h3> The severity of viral infections can vary widely, from asymptomatic cases to complications leading to hospitalizations and death. Milder cases, despite being more prevalent, often go undocumented, and their public health burden is not accurately estimated. <h3>Objective</h3> To estimate the true burden of influenza-like illness (ILI) in the US population using a surrogate measure of daily steps lost as measured by commercial wearable sensors. <h3>Design, Setting, and Participants</h3> This cohort study modeled data from 15 122 US adults who reported ILI symptoms during the 2018-2019 influenza season (before the COVID-19 pandemic) and who had a sufficient density of wearable sensor data at symptom onset. Participants' minute-level step data as measured by commercial wearable sensors were collected from October 1, 2018, through June 30, 2019. Minute-level activity time series were transformed into day-level time series per user, indicating the total number of steps daily. <h3>Main Outcomes and Measures</h3> The primary end point was the number of steps lost during the period of 4 days before symptom onset (the latent phase) through 11 days after symptom onset (the symptomatic phase). The association between covariates and steps lost during this interval was also examined. <h3>Results</h3> Of the 15 122 participants in this study, 13 108 (86.7%) were women, and the median age was 32 years (IQR, 27-38 years). For their ILI event, 2836 of 15 080 participants (18.8%) sought medical attention, and only 61 (0.4%) were hospitalized. Over the course of an ILI lasting 10 days, the mean cumulative loss was 4437 steps (95% CI, 4143-4731 steps). After weighting, there was an estimated overall nationwide reduction in mobility equivalent to 255.2 billion steps (95% CI, 232.9-277.6 billion steps) lost because of ILI symptoms during the study period. This finding reflects significant changes in routines, mobility, and employment and is equivalent to 15% of the active US population becoming completely immobilized for 1 day. Moreover, 60.6% of this reduction in steps (154.6 billion steps [95% CI, 138.1-171.2 billion steps]) occurred among persons who sought no medical care. Age and educational level were positively associated with steps lost. <h3>Conclusions and Relevance</h3> These findings suggest that most of the burden of ILI in this study would have been invisible to health care and public health reporting systems. This approach has applications for public health, health care, and clinical research, from estimating costs of lost productivity at population scale, to measuring effectiveness of anti-ILI treatments, to monitoring recovery after acute viral syndromes such as during long COVID-19.
Head‐to‐head comparison between recommendations by the <scp>ESC</scp> and <scp>ACC</scp>/<scp>AHA</scp>/<scp>HFSA</scp> heart failure guidelines
Authors: Antoni Bayés‐Genís, Alberto Aimo, Marco Metra, Stefan Anker, Petar Seferovic, Claudio Rapezzi, Vincenzo Castiglione, Julio Núñez, Michele Emdin, Giuseppe Rosano, Andrew J.S. Coats
Journal: European Journal of Heart Failure (2022)
Futility
Authors: Martin H. Ellbogen
Journal: Annals of Internal Medicine (2022)

Ad LibitumMay 2022FutilityMartin H. Ellbogen Jr., MDMartin H. Ellbogen Jr., MDCasper, WyomingSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M21-3820 Audio Reading - “Futility” Audio. Michael A. LaCombe, MD, Annals Associate Editor, reads “Futility” by Martin H. Ellbogen Jr., MD Your browser does not support the audio element. Audio player progress bar Step backward in current audio track Play current audio trackPause current audio track Step forward in current audio track Mute current audio trackUnmute current audio track 00:00/ SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail I closed the door on beings being forced to breatheAnd left the hospitalBy way of The Healing GardenEmptySave a few denuded benches andSome skeletal treesJust weeks ago scorched with colorJust months ago surging with verdant consummation.Only a few shriveled leaves flutter in theShivery breezeCurling inward upon themselvesTheir veins stark grasping tentaclesDangling by slender tethersBuying timeSuspended above the earth that waits for themThat will have them Author, Article, and Disclosure InformationAffiliations: Casper, WyomingCorresponding Author: Martin H. Ellbogen Jr., MD; e-mail, [email protected]com. PreviousarticleNextarticle Advertisement Audio Reading - “Futility” Audio. Michael A. LaCombe, MD, Annals Associate Editor, reads “Futility” by Martin H. Ellbogen Jr., MD Your browser does not support the audio element. Audio player progress bar Step backward in current audio track Play current audio trackPause current audio track Step forward in current audio track Mute current audio trackUnmute current audio track 00:00/ FiguresReferencesRelatedDetails Metrics May 2022Volume 175, Issue 5Page: 760 ePublished: 17 May 2022 Issue Published: May 2022 Copyright & PermissionsCopyright © 2022 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...
<i>Notes from the Field: Escherichia coli</i> O157:H7 Outbreak in Children with <i>Clostridioides difficile</i> Colonization Associated with an Improperly Treated Swimming Pool — Pennsylvania, June 2021
Authors: Molly E. Nace, Jennifer L. Wallace, Kelly E. Kline, Nottasorn Plipat
Journal: MMWR Morbidity and Mortality Weekly Report (2022)

On June 7, 2021, the Pennsylvania Department of Health (PADOH) received multiple complaints of gastrointestinal illness from patrons of a community swimming pool.Two patrons reported positive Shiga toxin-producing Escherichia coli (STEC) and Clostridioides difficile from stool specimens.PADOH issued pool closure orders and initiated an outbreak response to identify a source and prevent additional illnesses.Confirmed cases were defined as isolation of E. coli O157:H7 or detection of Shiga toxin or Shiga toxin genes from stool specimens of persons who visited the pool during May 31-June 7, 2021.Probable cases were defined as three or more loose stools in 24 hours with nausea, vomiting, fever, or cramps in persons who visited the pool during the same time frame.C. difficile results were deemed incidental upon consultation with experts (LC McDonald, MD, CDC, personal communication, June 2021) and were not included in the case definition.Fifteen cases (nine confirmed, six probable) in persons aged 4-14 years were identified; 10 patients were male (Table ).All persons reported swimming at the pool on May 31, 2021, the seasonal opening date, and had no other common exposures.The total number of pool visitors on this date is unknown.Symptom onsets occurred during June 2-June 4, 2021.Thirteen patients sought medical evaluation, and six were hospitalized.Four received antibiotics for C. difficile.None developed hemolytic uremic syndrome.Early findings suggested an unusual association between exposure to a chlorinated swimming pool and infections caused by two pathogens susceptible to chlorine.Pool inspection revealed an automatic chlorinator malfunction.Recordkeeping was inconsistent with local requirements, and the few available records demonstrated at least one instance of no detectable chlorine.The pool reopened following chlorinator repair, after which no additional cases were identified.The investigation highlighted three important points regarding evaluation of outbreaks of childhood diarrheal disease.First, C. difficile testing is only recommended for children aged ≥2 years with prolonged or worsening diarrhea and risk factors, including immunocompromising conditions or relevant exposures (e.g., recent health care visits or antibiotics).*Reported prevalence of asymptomatic C. difficile colonization might vary by study population,
Determining thresholds for spatial urban design and transport features that support walking to create healthy and sustainable cities: findings from the IPEN Adult study
Authors: Ester Cerin, James F Sallis, Deborah Salvo, Erica Hinckson, Terry L Conway, Neville Owen, Delfien van Dyck, Melanie Lowe, Carl Higgs, Anne Vernez Moudon, Marc A Adams, Kelli L Cain, Lars Breum Christiansen, Rachel Davey, Jan Dygrýn, Lawrence D Frank, Rodrigo Reis, Olga L Sarmiento, Deepti Adlakha, Geoff Boeing, Shiqin Liu, Billie Giles-Corti
Journal: The Lancet Global Health (2022)

An essential characteristic of a healthy and sustainable city is a physically active population. Effective policies for healthy and sustainable cities require evidence-informed quantitative targets. We aimed to identify the minimum thresholds for urban design and transport features associated with two physical activity criteria: at least 80% probability of engaging in any walking for transport and WHO's target of at least 15% relative reduction in insufficient physical activity through walking. The International Physical Activity and the Environment Network Adult (known as IPEN) study (N=11 615; 14 cities across ten countries) provided data on local urban design and transport features linked to walking. Associations of these features with the probability of engaging in any walking for transport and sufficient physical activity (≥150 min/week) by walking were estimated, and thresholds associated with the physical activity criteria were determined. Curvilinear associations of population, street intersection, and public transport densities with walking were found. Neighbourhoods exceeding around 5700 people per km2, 100 intersections per km2, and 25 public transport stops per km2 were associated with meeting one or both physical activity criteria. Shorter distances to the nearest park were associated with more physical activity. We use the results to suggest specific target values for each feature as benchmarks for progression towards creating healthy and sustainable cities.